Shaver with blood vessel and nerve monitoring features

ABSTRACT

A surgical instrument for cutting a first tissue and detecting a second tissue includes a shaft, a cutting member, and a tissue monitor system. The shaft extends along a longitudinal axis and includes a shaft lumen and a shaft opening. The cutting member is disposed within the shaft lumen and configured to cyclically move from a first position to a second position relative to the shaft. The cutting member is further configured to cut a tissue portion of the first tissue for removal therefrom. The tissue monitor system is associated with at least one of the shaft or the cutting member configured to detect the second tissue distinct from the first tissue for selectively cutting and removing the first tissue relative to the second tissue.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.17/384,854, entitled “Shaver with Blood Vessel and Nerve MonitoringFeatures,” filed Jul. 26, 2021; which is a division of U.S. patentapplication Ser. No. 15/984,473, entitled “Shaver with Blood Vessel andNerve Monitoring Features,” filed May 21, 2018, and issued as U.S. Pat.No. 11,103,256 on Aug. 31, 2021.

BACKGROUND

Surgical cutting instruments configured for removal of lesions, polypsand fibroids within the nasal cavity are known. Some configurations mayinclude an elongated inner member rotatably coaxially disposed within atubular outer member. The distal end of the outer member includes anopening, and the distal end of the inner member includes cutting edges.The proximal ends of the two members may be connected to a handledirectly or via a detachable hub. The inner member may be hollow and incommunication with an aspiration port so that severed tissue, etc. canbe aspirated out through the hollow member. The cutting edges can haveany various configurations suitable for the particular type of tissue,such as bone tissue, to be done, with the opening configured tocooperate with the specific cutting edge configuration.

To use such surgical cutting instrument to address such tissues, theopening/cutting edge is advanced to the target surgical site, and theopening positioned adjacent the tissue to be removed. The opening may berepositioned to address tissue which could not be accessed with theinstrument in the previous position. Surgical cutting instruments with afixed opening allow surgeons to cut only in the direction of the fixedopening cutting. To access, cut and remove tissue at various locations,surgeons have to reposition the instrument at various angles; or in someinstances, change to other instruments having a more appropriatelyarranged opening.

It may be desirable to access, cut and remove tissue, such as bonetissue, at various locations without having to reposition or change thesurgical instrument. While several different surgical instruments andmethods of use have been made for tissue removal within the nasalcavity, it is believed that no one prior to the inventors has made orused the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a perspective view of a first exemplary surgical cuttinginstrument having a handle assembly and a first shaft assembly;

FIG. 2 depicts an exploded perspective fragmentary view of the shaftassembly of FIG. 1 having a shaft and a cutting member;

FIG. 3 depicts an enlarged perspective view of a second exemplarysurgical cutting instrument having a pair of tissue sensors for a tissuemonitor system;

FIG. 4 depicts an enlarged perspective view of a third exemplarysurgical cutting instrument having another pair of tissue sensors for atissue monitor system;

FIG. 5 depicts a diagrammatic view of a nerve tissue monitor system;

FIG. 6A depicts a schematic view of a display of the nerve tissuemonitor system of FIG. 5 in use without the presence of nerve tissuebeing detected;

FIG. 6B depicts the schematic view of the display similar to FIG. 6A,but showing the nerve tissue monitor system in use with the presence ofnerves being detected;

FIG. 7 depicts a diagrammatic view of a vessel tissue monitor system;and

FIG. 8 depicts a schematic view of a display of the vessel tissuemonitor system of FIG. 7 in use with the presence of blood vessels beingdetected.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “side,” “axial,” and “longitudinal”also are used herein for reference to relative positions and directions.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. EXEMPLARY SURGICAL CUTTING INSTRUMENT

FIG. 1-2 show a first exemplary surgical cutting instrument (10) thatmay be used to remove tissue, such as bone tissue, from the nasalcavity, as well as from any other suitable location. Surgical cuttinginstrument (10) of the present example includes a handle assembly (12),a hub (14), and a first shaft assembly (16) extending distally fromhandle assembly (12). Handle assembly (12) has a handle (18) which maybe of any suitable configuration. Handle (18) may include controls forthe operation of surgical cutting instrument (10), or the controls maybe located remotely. Surgical cutting instrument (10) further includes asuction port (20) operatively connected to a vacuum source (22) andconfigured to enable aspiration of tissue, such as a bone tissue, from asurgical site. Rotational motion is delivered by a motorized driveassembly (24) within handle assembly (12) to shaft assembly (16) in thepresent example, although any suitable rotational or oscillatory motionsource may be utilized. For example, such motion source may be housedwithin handle assembly (12) or may be external and connectable to handleassembly (12). A power source (26) connects to motorized drive assembly(24) to power surgical cutting instrument (10) for use. In addition oralternatively, handle assembly (12) may house a battery (not shown).

Shaft assembly (16) generally includes an outer shaft (28) and an innercutting member (30) collectively configured to receive and remove tissuefrom the surgical site. Cutting member (30), which is illustrated as atube, is disposed within a longitudinally extending lumen (32) of shaft(28). Cutting member (30) is configured to be rotated about alongitudinal axis (42) of shaft assembly (16) at a distal portion.Although shaft assembly (16) is depicted as rigid, all or a portion ofshaft assembly (16) may be flexible, with longitudinal axis (42)comprising a series of cross-sectional centers. Cutting member (30)defines a lumen and extends proximally to handle assembly (12) andconnects to motorized drive assembly (24), which rotatably drivescutting member (30) relative to shaft (28). In the present example,shaft (28) is formed of polycarbonate and cutting member (30) is formedof stainless steel. Of course, shaft (28) and cutting member (30) may beformed of one or more alternative materials in accordance with theinvention described herein. The invention is thus not intended to beunnecessarily limited to manufacture with polycarbonate and stainlesssteel. While the present example of cutting member (30) is a hollowtube, cutting member (30) is not limited to being tubular and definingits own lumen (32).

Shaft (28) includes a window region (48) having a shaft opening, such asa shaft window opening (50), at distal portion. Distal portion includesa tubular sidewall (51) that distally terminates in a curved end, suchas a generally hemispherical end (52). Shaft window opening (50) extendsthrough tubular sidewall (51) of shaft (28) into central lumen (40) andis in fluid communication with the environment surrounding shaft (28).Shaft window opening (50) faces radially outward relative tolongitudinal axis (42) such that tissue is configured to be radiallyreceived through shaft window opening (50) into central lumen (40) in aradially inward direction. Shaft window opening (50) is surrounded by arelatively dull edge (53).

Cutting member (30) includes a cutting window opening (54) at distalportion of cutting member (30). Cutting window opening (54) isconfigured to longitudinally align with shaft window opening (50) andincludes a cutting edge (58) extending therealong. It is noted that lessthan the entirety of cutting edge (58) may be configured for cuttingtissue against an opposing edge (53) of shaft (28). At least a portionof cutting edge (58) is disposed to move adjacent to and across at leasta portion of window region (48) when cutting member (30) is rotated oroscillated about longitudinal axis (42). By way of example, as cuttingmember (30) moves in a clockwise direction, edge (53) of window region(48) provides an opposing surface to cutting edge (58) whereby tissuemay be severed to remove a cut tissue portion therefrom. Cutting edge(58) and edge (53) may have any configuration which suitably cooperateswith the other to sever tissue, such as a knife edge, a serrated edge,bipolar, monopolar or harmonic energy modality, or laser activatedcutting edge.

The extent of movement and position of cutting edge (58) relative toedge (53) is sufficient to separate tissue, whether by severing, tearingor any other mechanism. For example, cutting edge (58) may cyclicallymove across at least a portion of window region (48). Further clockwisemovement of cutting member (30) will advance cutting edge (58) past edge(53), such as results from oscillation about longitudinal axis (42) orfrom full rotation about longitudinal axis (42).

With continued reference to FIGS. 1-2 , vacuum source (22) generatessuction in a proximal direction along longitudinal axis (42) towardsuction port (20). Without tissue blocking cutting window opening (54),such suction proximally withdraws a window airflow therethrough alonglumen. However, once tissue is respectively introduced into windowopening (54), suction effectively draws tissue into window opening (54)for resection while tissue blocks airflow along lumen. Airflow throughlumen essentially terminates such that vacuum source (22) accumulatesthe vacuum within lumen. Such termination of airflow may generally bereferred to as a stalled airflow within lumen. Additional detailsregarding airflow through lumen and aspiration vents for improving suchairflow are discussed in alternative examples described in U.S. patentapplication Ser. No. 15/795,473, entitled “Tissue Shaving Instrument,”filed Oct. 27, 2017, issued as U.S. Pat. No. 10,631,890 on Apr. 28,2020, the disclosure of which is incorporated by reference herein.

Furthermore, surgical cutting instrument (10) may be used in conjunctionwith an image-guide surgery (IGS) navigation system, medical procedurechair, and displays described alone or in any combination according tothe following: U.S. Pat. Pub. No. 2016/0008083, entitled “GuidewireNavigation for Sinuplasty,” published Jan. 14, 2016, issued as U.S. Pat.No. 10,463,242 on Nov. 5, 2019; U.S. Patent App. No. 62/555,824,entitled “Apparatus to Secure Field Generating Device to Chair,” filedSep. 8, 2017; U.S. Pat. Pub. No. 2016/0008083, entitled “GuidewireNavigation for Sinuplasty,” published Jan. 14, 2016, issued as U.S. Pat.No. 10,463,242 on Nov. 5, 2019; U.S. Pat. Pub. No. 2016/0310042,entitled “System and Method to Map Structures of Nasal Cavity,”published Oct. 27, 2016, issued as U.S. Pat. No. 10,362,965 on Jul. 30,2019; U.S. Pat. No. 8,702,626, entitled “Guidewires for Performing ImageGuided Procedures,” issued Apr. 22, 2014; U.S. Pat. No. 8,320,711,entitled “Anatomical Modeling from a 3-D Image and a Surface Mapping,”issued Nov. 27, 2012; U.S. Pat. No. 8,190,389, entitled “Adapter forAttaching Electromagnetic Image Guidance Components to a MedicalDevice,” issued May 29, 2012; U.S. Pat. No. 8,123,722, entitled“Devices, Systems and Methods for Treating Disorders of the Ear, Noseand Throat,” issued Feb. 28, 2012; U.S. Pat. No. 7,720,521, entitled“Methods and Devices for Performing Procedures within the Ear, Nose,Throat and Paranasal Sinuses,” issued May 18, 2010; U.S. Pat. Pub. No.2014/0364725, entitled “Systems and Methods for Performing Image GuidedProcedures within the Ear, Nose, Throat and Paranasal Sinuses,”published Dec. 11, 2014, now abandoned; U.S. Pat. Pub. No. 2014/0200444,entitled “Guidewires for Performing Image Guided Procedures,” publishedJul. 17, 2014, now abandoned; U.S. Pat. No. 9,198,736, entitled “Adapterfor Attaching Electromagnetic Image Guidance Components to a MedicalDevice,” issued Dec. 1, 2015; U.S. Pat. Pub. No. 2011/0060214, entitled“Systems and Methods for Performing Image Guided Procedures within theEar, Nose, Throat and Paranasal Sinuses,” published Mar. 10, 2011, nowabandoned; U.S. Pat. No. 9,167,961, entitled “Methods and Apparatus forTreating Disorders of the Ear Nose and Throat,” issued Oct. 27, 2015;and U.S. Pat. Pub. No. 2007/0208252, entitled “Systems and Methods forPerforming Image Guided Procedures within the Ear, Nose, Throat andParanasal Sinuses,” published Sep. 6, 2007, now abandoned, thedisclosures of each of the these references being incorporated byreference herein.

II. TISSUE MONITOR SYSTEMS FOR A SURGICAL CUTTING INSTRUMENT WITH ATISSUE SENSOR

While surgical cutting instrument (10) is configured to remove a targettissue as discussed above in greater detail, such surgical cuttinginstrument (10) may be used by an operator to inadvertently cut adesirable tissue, which would preferably remain intact within thepatient. Particularly in instances with small and/or complicated tissueanatomies, the target tissue may be relatively close and, in someinstances, even intertwined with the desirable tissue. The operator ofsurgical cutting instrument (10) may thus require significant skill andtime during treatment to carefully remove the target tissue surgicalcutting instrument (10) or risk inadvertently cutting or even removingsuch desirable tissue.

Various surgical cutting instruments (110, 210) discussed belowincorporate a tissue monitor system (182, 282) for detecting thedesirable tissue while removing the target tissue to thereby reduce thelikelihood of inadvertently damaging the desirable tissue during use.Two such surgical cutting instruments (110, 210) and tissue monitorsystems (182, 282) in the present examples cut and remove tissue withcutting edge (58) discussed above and a drill (230) discussed below,while detecting nerve tissue and/or blood vessels, but it will beappreciated that any such instruments configured for cutting tissuewithin the patient may be so used. To this end, any feature orassociated use of the various tissue monitor systems (182, 282) may beused alone or in combination with each other. For example, tissuemonitor system (182) is configured to detect nerve tissue, whereas,tissue monitor system (282) is configured to detect blood vessels, butsuch features are readily combinable such that an alternative tissuemonitor system may detect both nerve tissue and blood vessels in use.The invention is thus not intended to be unnecessarily limited to theparticular examples shown herein. In any case, like numbers providedbelow indicate like features discussed above in greater detail.

A. Various Surgical Cutting Instruments and Tissue Sensors

FIG. 3 shows a second exemplary surgical cutting instrument (110) havinga second shaft assembly (116) with an outer tube (128) and a pair oftissue sensors (180) for use with a nerve tissue monitor system (182)(see FIG. 5 ) and/or a vessel tissue monitor system (282) (see FIG. 7 )discussed below in greater detail. In this respect, each tissue sensor(180) is more particularly a nerve sensor electrode (180), but mayadditionally or alternatively be an infrared sensor (280) (see FIG. 4 )or an ultrasound sensor. Nerve sensor electrodes (180) are generallyconfigured to detect the desirable tissue by distinguishing thedesirable tissue from the target tissue in order to reduce thelikelihood of inadvertently damaging the desirable tissue during usewhile simultaneously removing the target tissue between cutting edge(58) and opposing edge (53).

In the present example, nerve sensor electrodes (180) are fixed to outertube (128) such that shaft window opening (50) is positioned between thepair of nerve sensor electrodes (180). More particularly, shaft windowopening (50) includes longitudinally extending edges (53, 53′) that areparallel and angularly offset from each other about longitudinal axis(42). Each nerve sensor electrode (180) is angularly positionedproximate to respective edges (53, 53′) about longitudinal axis (42).Nerve sensor electrodes (180) thus collectively straddle shaft windowopening (50) about longitudinal axis (42) to increase the likelihood ofdetecting nerve tissue being introduced into shaft window opening (50)during use.

Each nerve sensor electrode (180) is electrically connected to a controlmodule (184) contained with handle assembly (12) (see FIG. 1 ). Inaddition, control module (184) is electrically connected to motorizeddrive assembly (24), which drives rotation of inner cutting member (30)(see FIG. 2 ). Based on detected nerve tissue via nerve sensorelectrodes (180), control module (184) thereby directs rotation of innercutting member (30) to either cease driving rotation of inner cuttingmember (30) or simply prevent rotation regardless of input provided bythe operator to inhibit damaging the detected desirable tissue.Alternatively, the operator may receive feedback of the detected tissuesuch that the operator may selectively direct movement of cutting member(30) as desired.

Alternatively, FIG. 4 shows a third exemplary surgical cuttinginstrument (210) having a third shaft assembly (216) with an outer tube(228) and a pair of tissue sensors (280) for use with nerve tissuemonitor system (182) (see FIG. 5 ) and/or vessel tissue monitor system(282) (see FIG. 7 ) discussed below in greater detail. In this respect,each tissue sensor (280) is more particularly an infrared sensor (280),but may be an alternative sensor, such as the ultrasound sensor.Infrared sensors (280) are generally configured to detect the desirabletissue by distinguishing the desirable tissue from the target tissue inorder to reduce the likelihood of inadvertently damaging the desirabletissue during use while simultaneously removing the target tissue withanother cutting member, such as a drill (230).

Outer tube (228) extends to a distal edge (232) surrounding a shaftopening of outer tube (228). Longitudinal axis (42) thus extendscoaxially through the shaft opening, which is configured to receivedrill (230) therethrough. More particularly, drill (230) has a pluralityof flutes (234) spiraling longitudinally therealong with a respectiveplurality of cutting edges (236). Each cutting edge (236) cuts thetarget tissue such that drill (230) is configured to bore a hole intothe target tissue for removing at least a portion of the target tissue.Drill (230) is connected to motorized drive assembly (24) such thatmotorized drive assembly (24) is configured to drive rotation of drill(230) relative to outer tube (228) during use.

In the present example, infrared sensors (280) face distally and extenddistally from distal edge (232) of outer tube (128) such that the shaftopening is positioned between the pair of infrared sensors (280). Moreparticularly, infrared sensors (280) are positioned on angularly opposedsides of outer tube (228) about longitudinal axis (42). Drill (230) withcutting edges (236) extends distally beyond distal edge (232) andinfrared sensors (280) such that cutting edges (236) cut the targettissue while infrared sensors (280) are configured to detect thedesirable tissue during use.

Each infrared sensor (280) is electrically connected to control module(184) contained with handle assembly (12) (see FIG. 1 ). In addition,control module (184) is electrically connected to motorized driveassembly (24). Based on detected blood vessels via infrared sensors(280), control module (184) thereby directs rotation of drill (230) toeither cease driving rotation of drill (230) or simply prevent rotationregardless of input provided by the operator to inhibit damaging thedetected desirable tissue. Alternatively, the operator may receivefeedback of the detected tissue such that the operator may selectivelydirect movement of drill (230) as desired.

B. Tissue Monitor Systems for Nerve Tissue and Blood Vessels

FIG. 5 shows nerve tissue monitor system (182) in greater detailincluding the pair of nerve sensor electrodes (180) and motorized driveassembly (24) connected to control module (184) as discussed brieflyabove. Control module (184) connects to a communication unit (186) thatwirelessly communicates with a console (188). To this end, nerve sensorelectrodes (180) are positioned on shaft assembly (116), whereas each ofcontrol module (184) and communication unit (186) are contained withinhandle assembly (12) and configured to exchange data remotely withconsole (188). In the present example, nerve sensor electrodes (180)continuously measure electrical parameters and communicate thosemeasurements to control module (184) and communication unit (186) to besent to console (188) for collection and processing for further control.

In the present example, console (188) includes a data acquisition system(190), a processor (192), a controller (194), and a feedback device,such as a display (198). Data acquisition system (190) collects themeasurement data provided by nerve sensor electrodes (180), andprocessor (192) processes the measurement data for visualizing ondisplay (198). In addition, processor (192) and controller (194) analyzethe measurement data to determine if nerve tissue is present acrossnerve sensor electrodes (180). Thereby, processor (192) and controller(194) are configured to detect such nerve tissue.

Controller (194) of the present example is further configured towirelessly communicate the status of detected nerve tissue back tocommunication unit (186). In the event that controller (184) detectsnerve tissue, controller (194) directs control module (184) todeactivate motorized drive assembly (24) in order to cease drivingcutting member (30). Thereby, controller (194) actively inhibits theoperator from inadvertently cutting the nerve tissue.

Additionally or alternatively, controller (194) may be configured toprovide passive feedback to the operator via display (198). For example,controller (194) directs display to visually generate images of themeasurement data for viewing by the operator as shown in FIGS. 6A-6B.FIG. 6A shows electrical measurements being approximately continuouswithout the detection of nerve tissue. In contrast, FIG. 6B shows aplurality of electrical measurement spikes (200) indicative of thepresence of nerve tissue. In the case of controller (194) activelyceasing movement of cutting member (30), the operator may overridecontroller (194) to continue driving cutting member (30) based on thepassive feedback visualized on display (198). In another example,control (194) may entirely prevent the operator from selectively drivingcutting member (30) while detecting nerve tissue. In the case ofreceiving the passive feedback via display (198), the operator mayeither continue to proceed with cutting, adjust the position of cuttingmember (30) to avoid the nerve tissue, and/or selectively cease drivingcutting member (30) for further inspection or adjustment.

While the feedback discussed above is visual, alternative feedback mayinclude audible feedback by an audible generator (not shown) or tactilefeedback by a tactile feedback generator (not shown). The particularfeedback provided herein is thus not intended to unnecessarily limit theinvention. Furthermore, various aspects of console (188) may becontained within shaft assembly (116) and/or handle assembly (12) inanother example such that wireless communication is reduced or simplyeliminated, and one or more components combined as desired. For example,functionality of control module (184) and controller (194) may becombined or separated as desired. The terms “control module” and“controller” are interchangeable and not intended to unnecessarily limitthe invention described herein. Furthermore, it will be appreciated thatsuch tissue monitor system (182) may be similarly configured fordetecting target tissue with one or more ultrasound sensors.

FIGS. 7-8 show vessel tissue monitor system (282) in greater detailincluding the pair of infrared sensors (280) and motorized driveassembly (24) connected to control module (184) as discussed brieflyabove. Similar to nerve tissue monitor system (182) (see FIG. 5 ),vessel tissue monitor system (282) also includes control module (184),communication unit (186) contained within handle assembly (12) as wellas data acquisition system (190), processor (192), and controller (194)contained within a console (288). In this respect vessel tissue monitorsystem (282) is configured to function similarly to nerve tissue monitorsystem (182) (see FIG. 5 ) such that like numbers indicate like featuresdiscussed above.

Console (288) differs from console (188) (see FIG. 5 ) with theinclusion of a projection display (298) configured to display aprojected image (300) onto an anatomy, such as a hand (302), of thepatient. In the present example, infrared sensors (280) detect bloodvessels, which are processed by processor (192) and directed bycontroller (194) to be projected by projection display (298) onto thehand (302). Projection display (298) visualizes blood vessels as aplurality of imaged blood vessels (304) projected and mapped directly onthe hand (302). The operator may thus selectively direct movement ofshaft assembly (216) while cutting the target tissue to avoid the bloodvessels (304) by using the mapped imaged blood vessels (304) as a guide.Again, it will be appreciated that such tissue monitor system (282) maybe similarly configured for detecting target tissue with one or moreultrasound sensors.

III. EXEMPLARY COMBINATIONS

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A surgical instrument, comprising: (a) a shaft extending along alongitudinal axis and including: (i) a shaft lumen extending along thelongitudinal axis, and (ii) a shaft opening in fluid communication withan environment and the shaft lumen; (b) a cutting member disposed withinthe shaft lumen and configured to cyclically move from a first positionto a second position relative to the shaft, wherein the cutting memberis configured to cut a tissue portion of a first tissue for removaltherefrom; and (c) a tissue monitor system associated with at least oneof the shaft or the cutting member, wherein the tissue monitor system isconfigured to detect a second tissue distinct from the first tissue forselectively cutting and removing the first tissue relative to the secondtissue.

Example 2

The surgical instrument of Example 1, wherein the tissue monitor systemfurther includes a first tissue sensor configured to detect the secondtissue.

Example 3

The surgical instrument of Example 2, wherein the tissue monitor systemfurther includes a second tissue sensor configured to further detect thesecond tissue.

Example 4

The surgical instrument of Example 3, wherein the first and secondtissue sensors are positioned on the shaft.

Example 5

The surgical instrument of any one or more of Examples 3 through 4,further comprising a motorized drive assembly operatively connected tothe cutting member and configured to drive the cutting member tocyclically move, wherein the tissue monitor system further includes acontroller operatively connected to the first and second tissue sensorsand the motorized drive assembly, wherein the controller is configuredto cease driving the cutting member when at least one of the first orsecond tissue sensors detect the second tissue.

Example 6

The surgical instrument of Example 5, wherein the controller isconfigured to cease driving the cutting member when each of the firstand second tissue sensors detect the second tissue.

Example 7

The surgical instrument of any one or more of Examples 2 through 6,further comprising a motorized drive assembly operatively connected tothe cutting member and configured to drive the cutting member tocyclically move, wherein the tissue monitor system further includes acontroller operatively connected to the first sensor and the motorizeddrive assembly, wherein the controller is configured to cease drivingthe cutting member when the first tissue sensor detects the secondtissue.

Example 8

The surgical instrument of Example 7, wherein the first tissue sensor ispositioned on the shaft.

Example 9

The surgical instrument of claim 2, wherein the first tissue sensor is afirst nerve sensor electrode configured to detect the second tissue inthe form of a nerve tissue.

Example 10

The surgical instrument of any one or more of Examples 2 through 9,wherein the first tissue sensor is a first infrared sensor configured todetect the second tissue in the form of a blood vessel.

Example 11

The surgical instrument of any one or more of Examples 1 through 10,wherein the tissue monitor system further includes a feedback deviceconfigured to indicate detection of the second tissue to an operator.

Example 12

The surgical instrument of Example 11, wherein the feedback deviceincludes a display configured to visually indicate detection of thesecond tissue to the operator.

Example 13

The surgical instrument of any one or more of Examples 1 through 12,further comprising a suction lumen extending along the longitudinal axisin fluid communication with the shaft opening and configured to connectto a vacuum source.

Example 14

The surgical instrument of any one or more of Examples 1 through 13,wherein the shaft opening is a shaft window opening configured toreceive the first tissue therein from the environment, and wherein thecutting member further includes: (i) a cutting window opening in fluidcommunication with the shaft window opening in the first position andconfigured to receive the first tissue therein, (ii) a cutting edge atleast partially surrounding the cutting window opening and configured tobe cyclically moved within the shaft lumen adjacent to the shaft edgefor cutting the tissue portion from the first tissue between the cuttingedge and the shaft edge, and (iii) a suction lumen extending along thelongitudinal axis in fluid communication with the cutting window openingand configured to connect to a vacuum source, wherein the suction lumenis in fluid communication with the cutting window opening and the shaftwindow opening in the first position.

Example 15

The surgical instrument of any one or more of Examples 1 through 14,wherein the shaft opening is coaxially aligned with the longitudinalaxis, wherein the cutting member further includes: (i) a drillprojecting distally from the shaft opening, and (ii) a plurality ofcutting edges extending along the drill configured to cut the tissueportion from the first tissue.

Example 16

A surgical instrument, comprising: (a) a shaft extending along alongitudinal axis and including: (i) a shaft lumen extending along thelongitudinal axis, and (ii) a shaft opening in fluid communication withan environment and the shaft lumen; (b) a cutting member disposed withinthe shaft lumen and configured to cyclically move from a first positionto a second position relative to the shaft, wherein the cutting memberis configured to cut a tissue portion of a first tissue for removaltherefrom; (c) a motorized drive assembly operatively connected to thecutting member and configured to drive the cutting member to cyclicallymove; and (d) a tissue monitor system associated with at least one ofthe shaft or the cutting member, wherein the tissue monitor system isconfigured to detect a second tissue distinct from the first tissue forselectively cutting and removing the first tissue relative to the secondtissue, wherein the tissue monitor system includes: (i) a first tissuesensor positioned on the shaft, (ii) a second tissue sensor positionedon the shaft, and (iii) a controller operatively connected to the firstand second tissue sensors and the motorized drive assembly, wherein thecontroller is configured to cease driving the cutting member when atleast one of the first or second tissue sensors detect the secondtissue.

Example 17

The surgical instrument of Example 16, wherein the controller isconfigured to cease driving the cutting member when each of the firstand second tissue sensors detect the second tissue.

Example 18

The surgical instrument of any one or more of Examples 16 through 17,wherein the shaft opening is a shaft window opening positioned angularlybetween the first and second tissue sensors about the longitudinal axisand configured to receive the first tissue therein from the environment,and wherein the cutting member further includes: (i) a cutting windowopening in fluid communication with the shaft window opening in thefirst position and configured to receive the first tissue therein, (ii)a cutting edge at least partially surrounding the cutting window openingand configured to be cyclically moved within the shaft lumen adjacent tothe shaft edge for cutting the tissue portion from the first tissuebetween the cutting edge and the shaft edge, and (iii) a suction lumenextending along the longitudinal axis in fluid communication with thecutting window opening and configured to connect to a vacuum source,wherein the suction lumen is in fluid communication with the cuttingwindow opening and the shaft window opening in the first position.

Example 19

The surgical instrument of any one or more of Examples 16 through 18,wherein the shaft has a distal edge and the shaft opening is coaxiallyaligned with the longitudinal axis surrounded by the distal edge,wherein the first and second tissue sensors are positioned on the distaledge, and wherein the cutting member further includes: (i) a drillprojecting distally from the distal edge and the shaft opening, and (ii)a plurality of cutting edges extending along the drill configured to cutthe tissue portion from the first tissue.

Example 20

A method of cutting a first tissue proximate to a second tissue with asurgical instrument including a shaft, a cutting member, and a tissuemonitor system, wherein the shaft extends along a longitudinal axis andincludes a shaft lumen extending along the longitudinal axis and a shaftopening in fluid communication with an environment and the shaft lumen,wherein the cutting member is disposed within the shaft lumen andconfigured to cyclically move from a first position to a second positionrelative to the shaft, wherein the cutting member is configured to cut atissue portion of the first tissue for removal therefrom, wherein thetissue monitor system is associated with at least one of the shaft orthe cutting member, wherein the tissue monitor system is configured todetect the second tissue distinct from the first tissue, the methodcomprising: (a) cutting the tissue portion from the first tissue withthe cutting member; (b) detecting the second tissue with the tissuemonitor system while cutting the tissue portion from the first tissue;and (c) ceasing movement of the cutting member after detecting thesecond tissue to thereby inhibit cutting the second tissue.

IV. MISCELLANEOUS

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1.-20. (canceled)
 21. A surgical instrument, comprising: (a) a shaftdefining a lumen and a laterally presented window opening, the lumen andthe laterally presented window opening being in communication with eachother, the laterally presented window opening being configured toreceive a first tissue therein from the environment, the shaftcomprising a shaft edge at least partially surrounding the laterallypresented window opening; (b) a cutting member comprising a cutting edgeconfigured to be cyclically moved within the lumen of the shaft adjacentto the shaft edge for cutting a tissue portion of the first tissue forremoval therefrom; and (c) a tissue monitor system associated with atleast one of the shaft or the cutting member, the tissue monitoringsystem being configured to detect a second tissue distinct from thefirst tissue for selectively cutting and removing the first tissuerelative to the second tissue, the tissue monitor system comprising afirst tissue sensor configured to detect the second tissue, the firsttissue sensor being elongate and extending along a majority of a lengthof the laterally presented window opening.
 22. The surgical instrumentof claim 21, the tissue monitor system further comprising a secondtissue sensor configured to detect the second tissue.
 23. The surgicalinstrument of claim 22, the second tissue sensor being elongated andextending along the laterally presented window opening.
 24. The surgicalinstrument of claim 21, the surgical instrument further comprising amotor configured to drive movement of the cutting edge relative to theshaft edge.
 25. The surgical instrument of claim 24, the tissue monitorsystem being in communication with the motor.
 26. The surgicalinstrument of claim 25, further comprising a control module incommunication with the tissue monitoring system, the control modulebeing configured to receive tissue sensing signals from the tissuemonitor system.
 27. The surgical instrument of claim 26, the controlmodule being in communication with the motor, the control module beingconfigured to instruct the motor to cease driving movement of thecutting edge in response to the tissue monitor system detecting thesecond tissue.
 28. The surgical instrument of claim 21, the first tissuesensor comprising a nerve sensor electrode.
 29. The surgical instrumentof claim 28, the nerve sensor electrode being fixed to the shaft. 30.The surgical instrument of claim 21, the cutting member defining acutting window opening, the cutting edge at least partially surroundingthe cutting window opening.
 31. The surgical instrument of claim 30, thecutting window opening being configured to longitudinally align with thelaterally presented window opening.
 32. The surgical instrument of claim21, further comprising a vacuum source configured to generate a sourceof suction.
 33. The surgical instrument of claim 32, the vacuum sourceconfigured to draw suction proximally within the lumen of the shaft. 34.A surgical instrument, comprising: (a) a shaft defining a shaft lumenand a distal shaft opening, the distal shaft opening being in fluidcommunication with the shaft lumen, the shaft comprising a distal edge;(b) a cutting member at least partially disposed within the shaft lumen,the cutting member including a drill projecting distally from the distaledge of the shaft opening, the drill being configured to cut a tissueportion of a first tissue for removal therefrom; and (c) a tissuemonitor system associated with at least one of the shaft or the cuttingmember, the tissue monitor system being configured to detect a secondtissue distinct from the first tissue for selectively cutting andremoving the first tissue relative to the second tissue, the tissuemonitor system comprising a first tissue sensor positioned on the distaledge of the shaft.
 35. The surgical instrument of claim 34, furthercomprising a second tissue sensor also positioned on the distal edge ofthe shaft.
 36. The surgical instrument of claim 34, the first tissuesensor comprising an infrared sensor.
 37. The surgical instrument ofclaim 34, further comprising a motorized drive assembly configuredactuate the drill to cut the tissue portion of the first tissue.
 38. Thesurgical instrument of claim 37, the tissue monitor system furthercomprising a controller operatively connected to the first tissue sensorand the motorized drive assembly, the controller being configured tocease driving the cutting member when the first tissue sensor detectsthe second tissue.
 39. A surgical instrument, comprising: (a) a shaftdefining a lumen; (b) a cutting member disposed within the lumen of theshaft, the cutting member being configured to cut a tissue portion of afirst tissue for removal therefrom; and (c) a tissue monitor systemassociated with at least one of the shaft or the cutting member, thetissue monitor system being configured to detect a second tissuedistinct from the first tissue for selectively cutting and removing thefirst tissue relative to the second tissue, the tissue monitor systemcomprising: (i) a sensor configured to generate measurement data, (ii) acontrol module operatively connected to the sensor such that the controlmodule is configured to receive the measurement data from the sensor,(iii) a communication unit operatively connected to the control module,and (iv) a console in communication with the communication unit, theconsole comprising: (A) a data acquisition system configured to receivethe measurement data from the control module via the communication unit,(B) a processor configured to process the measurement data to determinea status of the second tissue, (C) a display configured to visualize theprocessed measurement data, and (D) a controller configured tocommunicate the status of the second tissue to the control module viathe communication unit.
 40. The surgical instrument of claim 39, thecommunication unit being in wireless communication with the console.